PMS-NIFEDIPINE ER TABLET (EXTENDED-RELEASE)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

NIFEDIPINE

Sẵn có từ:

PHARMASCIENCE INC

Mã ATC:

C08CA05

INN (Tên quốc tế):

NIFEDIPINE

Liều dùng:

60MG

Dạng dược phẩm:

TABLET (EXTENDED-RELEASE)

Thành phần:

NIFEDIPINE 60MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

DIHYDROPYRIDINES

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0115253005; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2013-11-21

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
PMS-NIFEDIPINE ER
Nifedipine Extended-Release Tablets, House Standard
20 mg, 30 mg and 60 mg Nifedipine
Antianginal/Antihypertensive Agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Revision:
December 14, 2016
Submission Control No: 200335
_ _
_pms-NIFEDIPINE ER Product Monograph _
_Page 2 of 43_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
CLINICAL TRIALS
........................................................................................................